Purdue seeks rule that would give it edge in Canadian painkiller market

FILE PHOTO - Prescription painkiller OxyNEO by Purdue Pharma is shown at a pharmacy, with "X" indicating not a full bottle, in Toronto, Ontario, Canada on January 17, 2017. REUTERS/Hyungwon Kang/File Photo

TORONTO, Canada (Reuters) - A leading drugmaker ramped up its lobbying in Canada fivefold last year, urging government officials to enact a rule that would give it an effective monopoly on long-acting narcotic painkillers.

Purdue Pharma’s efforts came as the government pledged a new attack on the county’s deadly opioid crisis. The privately owned maker of the blockbuster OxyContin pushed for a requirement that all long-acting narcotic painkillers, known as opioids, be made tamper resistant.

The company, which sells the only tamper-resistant, long-acting opioids in Canada, met with 40 officeholders last year, up from eight in 2015 and three in 2014, records show.

The rule it proposed could edge out companies that don’t sell tamper-resistant opioids, including Novartis’, Sandoz AG <Sandoz AG>, Johnson & Johnson’s Janssen, Teva, Pharmascience and Apotex SA <Apotex SA> and others. Purdue said other companies make tamper-resistant opioids that they could seek approval for in Canada.

Purdue’s lobbying illustrates the stakes for drugmakers in efforts to curb what policymakers have called North America’s biggest public health crisis.

Deaths involving opioids - including prescription painkillers, heroin and other street drugs - rose 38 percent in Ontario over the last five years and almost doubled in British Columbia in last year. More than 200,000 people have died in the U.S. epidemic.

Canada’s $881-million annual opioid sales are dwarfed by the U.S. market, the biggest in the world. Any action by Canada is likely to attract interest south of the border.

Purdue said it was pushing for the rule to improve safety. Canadian officials have passed on that proposal and instead are looking at measures that could hurt sales of long-acting opioids, including Purdue’s best-selling painkillers.

Health Minister Jane Philpott said she would begin taking steps this month to get cigarette-style warning stickers on all opioids and, next month, to rewrite Canada’s definition of appropriate use for long-acting opioids. [L1N1FD018]

An advisory group funded in part by Health Canada recommended in January setting a daily dosage cap for long-acting opioids and scaling back their use for chronic, non-cancer pain.

TAMPER-RESISTANCE DEBATE

Long-acting opioids contain high doses of narcotics designed to be released over time. If crushed pills are snorted or injected, they release their full dose all at once, which makes them dangerous and valuable among addicts.

In 2012, Purdue replaced OxyContin with tamper-resistant OxyNEO in Canada and now wants that standard mandated for all long-acting opioids.

”The abundance of published peer-reviewed evidence of the positive impact abuse-deterrent technologies have on public health supports Purdue Pharma (Canada)’s view that making all prescription opioids less vulnerable to misuse, abuse and diversion, while retaining their safety and efficacy, is necessary,” spokesperson Sarah Robertson wrote in an email.

Many experts and public health officials see the research differently. They said there’s little evidence tamper resistance reduces addiction or death and that it may even prompt doctors to more readily prescribe opioids.

Research shows opioids are most often abused not by crushing but by swallowing pills whole, said David Juurlink, a drug-safety researcher at Toronto’s Sunnybrook Health Sciences Centre.

”It’s very easy to get the sense that this push in favor of tamper-resistant opioids is rooted more in financial considerations than in the public interest,” he said.

The company said it’s only objective was safety.

Purdue Canada also sells a crushable long-acting opioid. Hydromorph Contin is a brand-name version of Canada’s top-selling opioid painkiller, hydromorphone, which has been involved in a growing number of overdose deaths. Purdue declined to say whether it had plans to make Hydromorph Contin tamper resistant.

Generics manufacturers said they do not view tamper resistance as the answer.

“We believe that efforts should be made to address the main root cause of opioid abuse and misuse, which appears to be over-prescribing,” Jeff Connell, Canadian Generic Pharmaceutical Association Vice-President, said in an email.

“There is no evidence that tamper-resistant formulations are effective in reducing the level of abuse of opioids,” a Sandoz spokesperson wrote in an email. Sandoz sells a long-acting, crushable oxycodone painkiller.

Health Canada issued a statement last April saying it had no plans to require tamper resistance.

Purdue sent lobbyists on four occasions to Health Canada officials last year, including a May meeting seeking an explanation for the government’s stance, department spokesperson Anna Maddison said in an email.

Conservative Member of Parliament Kevin Sorenson revived the idea in September with a bill to require all controlled substances be tamper resistant.

Records show Sorenson met with Purdue representatives six days before he introduced the bill and spoke with them again two days before it went to second reading in November.

The lobbyists expressed Purdue’s support for the bill, Sorenson’s spokesman Dan Wallace said in an email.

The bill needs majority support in the House of Commons, including at least eight members of the governing Liberals, to go to the Senate.

In October, Purdue Canada Chief Executive Craig Landau met with Public Safety Minister Ralph Goodale to discuss “efforts to combat opioid abuse,” said Scott Bardsley, a spokesperson for the minister.

Toronto-area Liberal Member of Parliament Jennifer O’Connell said Purdue sent a representative to talk to her when she was a candidate in 2015 and, records show, twice after she won.

“I found that interesting. I flat-out asked them, ‘Why is this in Purdue’s interest?’ And they said it was very altruistic, wanting to deal with the opioid crisis,” she said in an interview. “I did a little more research, and I realized … if the federal government were to regulate it for everyone else, they’d essentially have a monopoly.”